8210 Federal Register / Vol. 89, No. 25 / Tuesday, February 6, 2024 / Notices 

1Health professionals may include but are not 

limited to pediatricians, family physicians, 

product that is in finished package form, 

a drug product that is not in finished 

package form, an active pharmaceutical 

ingredient, and other types of listed 

drugs, except for biological products or 

categories thereof exempted by an order 

under section 510(j)(3)(B) of the FD&C 

Act). Listed drugs subject to reporting 

include human drug products 

(including non-exempt biological 

products) marketed under an approved 

application, animal drug products 

marketed under an approved 

application, medical gases, homeopathic 

products, products marketed in 

accordance with requirements under 

section 505G of the FD&C Act (21 U.S.C. 

355h), often referred to as over-thecounter monograph drugs, and animal 

drug products that are not approved, 

conditionally approved, or indexed 

under sections 512, 571, and 572 of the 

FD&C Act (21 U.S.C. 360b, 360ccc, and 

360ccc–1). 

This guidance finalizes the draft 

guidance entitled ‘‘Reporting Amount of 

Listed Drugs and Biological Products 

Under Section 510(j)(3) of the FD&C 

Act’’ published on November 1, 2021 

(86 FR 60249). FDA considered 

comments received on the draft 

guidance as the guidance was finalized. 

Changes from the draft to the final 

guidance include changes to the 

recommended timeframe for report 

submission, as well as changes to the 

recommended units for the reporting of 

drugs that are not drug products in 

finished package form. These changes 

were made in response to public 

comments received and in the interest 

of facilitating drug amount data 

submission and improving data 

accuracy. Revisions also were made to 

clarify the reporting requirements 

applicable to registrants of listed drugs 

across the drug supply chain, including 

contract manufacturers. Further 

revisions were made to clarify and 

further detail how FDA plans to use 

data derived from the drug amount 

reporting program, including data 

submitted by each registrant in the drug 

supply chain. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Reporting Amount 

of Listed Drugs and Biological Products 

Under Section 510(j)(3) of the FD&C 

Act.’’ It does not establish any rights for 

any person and is not binding on FDA 

or the public. You can use an alternative 

approach if it satisfies the requirements 

of the applicable statutes and 

regulations. 

II. Paperwork Reduction Act of 1995

While this guidance contains no

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3521). The collections of 

information in 21 CFR part 207 

pertaining to registration of producers of 

drugs and listing of drugs in commercial 

distribution have been approved under 

OMB control number 0910–0045. The 

collections of information in 21 CFR 

parts 314 and 601 have been approved 

under OMB control numbers 0910–0001 

and 0910–0338, respectively. The 

collections of information pertaining to 

notifications of discontinuance or 

interruption in manufacturing under 21 

CFR 310.306 and 314.81(b)(3)(iii) have 

been approved under OMB control 

number 0910–0001. The collections of 

information relating to 21 CFR 600.81 

and 600.82 have been approved under 

OMB control number 0910–0308. The 

collections of information in 21 CFR 

parts 210 and 211 relating to current 

good manufacturing practice have been 

approved under OMB control number 

0910–0139. The collections of 

information in 21 CFR 514.80 have been 

approved under OMB control number 

0910–0284. The collections of 

information in 21 CFR 514.87 have been 

approved under OMB control number 

0910–0659. 

III. Electronic Access

Persons with access to the internet

may obtain the guidance at https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, https://

www.fda.gov/vaccines-blood-biologics/ 

guidance-compliance-regulatoryinformation-biologics/biologicsguidances, https://www.fda.gov/animalveterinary/guidance-regulations/ 

guidance-industry, or https://

www.regulations.gov. 

Dated: February 1, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–02369 Filed 2–5–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Information 

Collection Request Title: Pediatric 

Mental Health Care Access Program 

National Impact Study 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than April 8, 2024. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14N39, 5600 Fishers 

Lane, Rockville, Maryland, 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Joella Roland, the HRSA 

Information Collection Clearance 

Officer, at (301) 443–3983. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the ICR title 

for reference. 

Information Collection Request Title: 

Pediatric Mental Health Care Access 

Program National Impact Study, OMB 

No. 0915–xxxx—[New]. 

Abstract: This notice describes an 

information collection request for one of 

HRSA’s Maternal and Child Health 

Bureau programs, the Pediatric Mental 

Health Care Access (PMHCA) Program. 

The PMHCA Program aims to promote 

behavioral health integration into 

pediatric primary care by supporting the 

development of state, regional, and 

tribal pediatric mental health care 

teleconsultation access programs. The 

PMHCA Program supports pediatric 

health professionals (HPs) 1 in their 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 25 / Tuesday, February 6, 2024 / Notices 8211 

physician assistants, advanced practice nurses/ 

nurse practitioners, licensed practical nurses, 

registered nurses, counselors, social workers, 

medical assistants, patient care navigators. 

delivery of high-quality and timely 

screening, assessment, treatment, and 

referrals for children and adolescents 

with behavioral health conditions 

through the provision of 

teleconsultation, care coordination 

support/navigation (e.g., resource 

identification and referrals), and 

training and education. 

The information will be collected 

from participants in HRSA PMHCA 

award recipient programs that were 

funded in 2021, 2022, or 2023. The 2021 

and 2022 PMHCA programs are 

authorized by 42 U.S.C 254c–19 (Title 

III, § 330M of the Public Health Service 

Act), using funding appropriated by 

Section 2712 of the American Rescue 

Plan Act of 2021 (Pub. L. 117–2), and 

the 2023 PMHCA programs are 

authorized by 42 U.S.C 254c–19 (§ 330M 

of the Public Health Service Act), as 

amended by section 11005 of the 

Bipartisan Safer Communities Act (Pub. 

L. 117–159). To examine the impact of 

the PMHCA program on children and 

adolescents, this data collection will use 

two instruments: the HP Impact Survey 

and the Family/Caregiver Focus Group 

Discussion (FGD). Additionally, family 

members/caregivers identified by 

PMHCA programs to participate in the 

Family/Caregiver FGD will be asked 

demographic questions (Family/ 

Caregiver Demographic Questionnaire) 

about themselves and their child/ 

adolescent for the purpose of FGD 

sampling and to inform qualitative data 

analyses. 

Need and Proposed Use of the 

Information: This information is needed 

by HRSA to examine PMHCA program 

impacts on children/adolescents and 

their families/caregivers in order to 

guide future program decisions. 

Specifically, data collected for the 

PMHCA Impact Study will be used to 

examine changes in children’s and 

adolescents’ and their families’/ 

caregivers’ access to behavioral health 

care; their subsequent receipt and 

utilization of behavioral health care, 

including culturally and linguistically 

appropriate care; related behavioral 

health impacts; and monetary and 

societal cost-benefits. The study will 

examine changes over time regarding 

enrolled/participating HPs’ practices 

with screening, diagnosing, treating, and 

referring children and adolescents with 

behavioral health conditions and assess 

their perceptions of the behavioral 

health impact of the PMHCA Program. 

Additionally, the study will deepen 

understanding of families’/caregivers’ 

experiences with behavioral health care 

access, receipt, and utilization; 

satisfaction with behavioral health care 

services; and the impact of behavioral 

health services on their children/ 

adolescents. 

Likely Respondents: 

• HP Impact Survey: Pediatricians, 

family physicians, physician assistants, 

advanced practice nurses/nurse 

practitioners, licensed practical nurses, 

registered nurses, counselors, social 

workers, medical assistants; 

• Family/Caregiver FGD: Family 

members and caregivers who have 

sought and/or received behavioral 

health care for their child(ren)/ 

adolescent(s); and 

• Family/Caregiver Demographic 

Questionnaire: Family members and 

caregivers who have sought and/or 

received behavioral health care for their 

child(ren)/adolescent(s). 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose, or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating, and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

Total Estimated Annualized Burden 

Hours: 

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total 

burden 

hours 

HP Impact Survey .................................................................... 21,070 2 42,140 0.17 7,163.80 

Family/Caregiver FGD ............................................................. 42 1 42 1.00 42 

Family/Caregiver Demographic Questionnaire ........................ 270 1 270 .08 21.60 

Total .................................................................................. 21,382 ........................ 42,452 ........................ 7,227.40 

HRSA specifically requests comments 

on: (1) the necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions; (2) the accuracy of the 

estimated burden; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) the 

use of automated collection techniques 

or other forms of information 

technology to minimize the information 

collection burden. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2024–02357 Filed 2–5–24; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Ryan White HIV/AIDS Program Part C 

Early Intervention Services 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice of supplemental award. 

SUMMARY: HRSA expects the availability 

of additional funds for the RWHAP Part 

C Early Intervention Services (EIS) 

Program due to relinquishments, 

reductions, closeouts, and unawarded 

fiscal year (FY) 2023 new service area 

competition funds in the estimated 

amount of $4.2 million and intends to 

distribute these supplemental funds 

across the current cohort of RWHAP 

Part C EIS recipients. The amount is 

subject to change depending on the 

availability of additional funds. 

FOR FURTHER INFORMATION CONTACT: 

CAPT Mahyar Mofidi, Director, Division 

of Community HIV/AIDS Programs, 

HIV/AIDS Bureau, Health Resources 

and Services Administration, at 

mmofidi@hrsa.gov or 301–443–2075. 


ddrumheller on DSK120RN23PROD with NOTICES1